BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 240530 · Received September 16, 1999

    Report

    Report Number
    1811212-1999-00003
    Event Type
    Injury
    Date Received
    September 16, 1999
    Date of Event
    August 2, 1999
    Report Date
    September 16, 1999
    Manufacturer
    FERNDALE LABORATORIES, INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FOLLOWING CYSTOFYBROMA SURGERY ON KNEE (7/23/1999), THE INCISION SITE WAS CLEANED WITH HYDROGEN PEROXIDE AND STERI-STRIPS WERE SECURED WITH MASTISOL. SHE RETURNED ON 8/2/1999 FOR A FOLLOW UP VISIT. BURNING, ITCHING, AND REDNESS HAD DEVELOPED AROUND THE AREA. (THE RED AREA ASSUMED THE SHAPE OF THE BANDAGE). SHE WAS EVENTUALLY TREATED IN THE ER FOR REDNESS AND ITCHING WITH HYDRAZONE CREAM. THE INCISION BECAME INFLAMMED AND THE AREA AROUND THE KNEE BEGAN TO SWELL. EVENTUALLY BLISTERS BEGAN TO DEVELOP. SHE REPORTS THAT THEY WERE APPROX 1 INCH IN DIAMETER AND 3/4 INCH IN HEIGHT AND CONTAINED YELLOW LIQUID. SHE WAS TREATED A SECOND TIME AT THE ER WITH ANTIBIOTICS, TETANUS SHOT, AND GIVEN A PRESCRIPTION FOR ANTIBIOTIC. PT CALLED BACK ON 8/5/1999 TO REPORT THAT ALTHOUGH THE BLISTERS WERE STILL PRESENT AND APPEARED SOMEWHAT REDUCED IN SIZE, THE REDNESS AND RASH APPEARED LARGER. SHE REPORTED THE AREA OF THE RASH TO BE APPROX 6" X 8" ON THE FRONT OF THE KNEE AND APPROX 12" X 8" ON THE BACK OF HER LEG. THE HEALTH CARE PROVIDER SUGGESTED THAT IT SPREAD TO THE BACK OF THE LEG BY CROSS CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTISOL LIQUID ADHESIVE KGX FERNDALE LABORATORIES, INC * 57-089

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN